Title:Intestinal Failure, Short Gut Syndrome and Small Bowel
Transplantation (R01)

Announcement TypeThis is a reissue of PA-02-163 which was previously released September 9, 2002.

Update: The following update relating to this announcement has been issued:

November 20, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-010, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.

Looking ahead: As part of the Department of Health and Human Services'
implementation of e-Government, during FY 2006 the NIH will gradually
transition each research grant mechanism to electronic submission through
Grants.gov and the use of the SF 424 Research and Related (R&R) forms.
Therefore, once the transition is made for a specific grant mechanism,
investigators and institutions will be required to submit applications
electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH
Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also
clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is
required. Investigators should consult the NIH Forms and Applications Web site
(http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant
application.

The National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK) seeks grant applications to study the pathogenesis,
natural history, treatment and complications of intestinal failure and its
therapies, including parenteral nutrition and small bowel transplantation.

This funding opportunity will
utilize the National Institutes of Health (NIH) research project grant (R01)
mechanism, but will be run in parallel with a program announcement of
identical scientific scope (PA-06-229)
that will utilize the Exploratory/Developmental Research grant (R21).

Because the nature and scope of
the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. The
total amount awarded and the number of awards will depend upon the
mechanism numbers, quality, duration, and costs of the applications
received.

Eligible organizations include:

For-profit
or non-profit organizations

Public
or private institutions, such as universities, colleges, hospitals, and
laboratories

Units
of State and local governments

Eligible
agencies of the Federal government

Domestic
or foreign

Eligible principal investigators
include any individual with the skills, knowledge and resources necessary
to carry out the proposed research is invited to work with their
institution to develop an application for support.

Applicants may submit more than
one application, provided they are scientifically distinct.

Intestinal failure, which is defined as reduced
absorption of nutrients from the gastrointestinal tract resulting in the need
for parenteral nutrition for survival, has many causes, including primary
defects of intestinal epithelial absorption, motility disorders, and loss of
large portions of the intestine due to surgical resection for congenital
defects, necrotizing enterocolitis, ischemia, trauma, and inflammatory bowel
disease. It is estimated that 20,000 individuals in the United States are supported by parenteral nutrition for intestinal failure and that the economic and
quality of life burden for these patients is very high. A small fraction of
these patients undergo small bowel transplantation, a treatment with significant
morbidity, mortality, and high cost. Thus, new fundamental discoveries that
lead to ways to prevent intestinal failure or its complications, to improve
existing therapies, parenteral nutrition or small bowel transplantation, or to
devise novel therapies, could lead to a significant improvement in quality of
life and decreased cost of care for patients suffering from intestinal failure.

Scope and Objectives

The overall objective of this funding
opportunity is to encourage basic and clinical research into intestinal
failure, short gut syndrome and intestinal transplantation. There are many
causes of intestinal failure, each of which has varying degrees of information
regarding etiology and pathogenesis. Intestinal failure can be due to
intrinsic diseases of the gastrointestinal tract or result from major loss or
resection of the intestine (short gut syndrome). By definition, therapy for
intestinal failure relies on parenteral nutrition, usually in conjunction with
oral nutritional support. While some patients may survive indefinitely using
parenteral and oral nutritional support, others suffer multiple complications,
such as recurrent infection, dehydration, vascular thrombosis, or progressive
liver disease that may result in death. A small number of patients with these
complications may be rescued by small bowel transplantation, which itself is
associated with numerous potential complications and requirement for lifelong
immunosuppression.

The specific objectives of this funding
opportunity are to encourage research addressing the overall problem of
intestinal failure, which may include, but is not restricted to any of the
following topics:

Studies
of the etiology and pathogenesis of intestinal failure where the cause is not
well understood, especially necrotising enterocolitis in infancy, congenital
developmental defects, motility disorders, defects of transport such as
microvillus inclusion disease, and early childhood inflammatory disorders of
the gut.

Studies
of the genetic and molecular basis of gut development in animal models that may
lead to novel insights into intestinal failure.

Basic
and clinical studies of gut adaptation to intestinal failure, including the
role of nutrients, endogenous factors such as growth factors, intestinal flora,
and therapeutic agents.

Studies
to define nutrient requirements, either oral or parenteral, necessary to
maintain optimal health for patients with intestinal failure.

Studies
of the complications of intestinal failure and its therapy, particularly the
etiology, diagnosis and treatment of liver disease associated with parenteral
nutrition.

Basic
or clinical research in small bowel transplantation, either in animal models or
humans, that aim to improve multiple aspects of transplantation, including
patient selection, transplantation procedures, nutritional support,
immunosuppression, and tolerance induction.

Research
to improve diagnosis or treatment of complications of small bowel
transplantation, including graft rejection, infections or diarrhea of unknown
etiology following transplantation.

This funding opportunity
will use the National Institutes of Health (NIH) research project grant (R01) award
mechanism.

As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.

This funding opportunity
uses just-in-time concepts. It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular budget format described in the PHS
398 application instructions. Otherwise follow the instructions for non-modular
research grant applications.

2. Funds Available

Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.

Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 awards.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an)
application(s) if your organization has any of the following characteristics:

For-profit organizations

Non-profit organizations

Public or private institutions,
such as universities, colleges, hospitals, and laboratories

Units of State government

Units of local government

Eligible agencies of the Federal
government

Foreign Institutions

Domestic Institutions

1.B.
Eligible Individuals

Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their institution to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH programs.

Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.

The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.

Foreign Organizations

Several special provisions apply to applications
submitted by foreign organizations:

Charge back of customs and import fees is not allowed.

Format: every effort should be made to comply with the
format specifications, which are based upon a standard US paper size of 8.5" x 11."

3.A.1.
Letter of IntentA letter of intent is
not required for the funding opportunity.

3.B. Sending an
Application to the NIH

Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:

Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.

The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous critique.

Although there is no
immediate acknowledgement of the receipt of an application, applicants are
generally notified of the review and funding assignment within eight (8) weeks.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new or competing continuation award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Specific
Instructions for Modular Grant applications.

Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular budget
format. The modular budget format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year.

Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps:

1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;

2) Obtain agreement
from the IC staff that the IC will accept your application for consideration
for award; and,

3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.

This policy applies to all
investigator-initiated new (type 1), competing continuation (type 2), competing
supplement, or any amended or revised version of these grant application types.
Additional information on this policy is available in the NIH Guide for Grants
and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research
Data
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can receive
the data and whether or not any conditions will be placed on their use), and
the mode of data sharing (e.g., under their own auspices by mailing a disk or
posting data on their institutional or personal website, through a data archive
or enclave). Investigators choosing to share under their own auspices may wish
to enter into a data-sharing agreement. References to data sharing may also be
appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of
the proposed research must include a plan for sharing research data in their
application. The funding organization will be responsible for monitoring the
data sharing policy ( http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not
sharing research data may be assessed by the reviewers. However, reviewers will
not factor the proposed data sharing plan into the determination of scientific
merit or the priority score.

The reasonableness of the data sharing plan or the rationale for not
sharing research data will be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or the priority score

The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.

Section
V. Application Review Information

1. Criteria

Only the review criteria
described below will be considered in the review process.

2. Review and Selection Process

Applications submitted
for this funding opportunity will be assigned to the ICs on the basis of
established PHS referral guidelines.

Undergo a
selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score.

Receive a
written critique

Receive a
second level of review by an appropriate national advisory council or board.

The
following will be considered in making funding decisions:

Scientific
merit of the proposed project as determined by peer review

Availability
of funds

Relevance
of program priorities

The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.

Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?

Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the principal investigator and other
researchers? Does the investigative team bring complementary and integrated
expertise to the project (if applicable)?

Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?

2.A. Additional Review
Criteria:

In addition to the above
criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:

Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed (see the Research Plan, Section E on Human Subjects in the PHS Form
398).

Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the research
will be assessed. Plans for the recruitment and retention of subjects will also
be evaluated (see the Research Plan, Section E on Human Subjects in the PHS
Form 398).

Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the environment,
determine if the proposed protection is adequate.

2.B. Additional Review
Considerations

Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.

Program staff will be
responsible for the administrative review of the plan for sharing research
resources.

The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section
VI.3. Reporting.

3. Anticipated Announcement and Award DatesNot Applicable

Section
VI. Award Administration Information

1. Award Notices

After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.

If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA\ will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the NoA
are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects
Protection:Federal regulations
(45CFR46) require that applications and proposals involving human subjects must
be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research
Data:Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not
possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.

Access to Research
Data through the Freedom of Information Act:The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of Model
Organisms:NIH is committed to
support efforts that encourage sharing of important research resources including
the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of Women
And Minorities in Clinical Research:It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children
as Participants in Clinical Research:The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.

Required Education on
the Protection of Human Subject Participants:NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem
Cells (hESC):Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.

NIH Public Access Policy:NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.

NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.

Standards for Privacy
of Individually Identifiable Health Information:The Department of Health
and Human Services (DHHS) issued final modification to the "Standards for
Privacy of Individually Identifiable Health Information", the
"Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable health
information, and is administered and enforced by the DHHS Office for Civil
Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant
Applications or Appendices:All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.

Healthy People 2010:The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in
the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages
all grant recipients to provide a smoke-free workplace and discourage the use
of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act
of 1994, prohibits smoking in certain facilities (or in some cases, any portion
of a facility) in which regular or routine education, library, day care, health
care, or early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and mental
health of the American people.

Loan Repayment
Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.